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The Lelo Hex Lubricated Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

The Lelo Hex Lubricated Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

It is a straight walled textured condom with a nipple end and made of natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. It has a nominal length of 190 ± 10 mm, nominal width of 54 ± 2 mm and nominal thickness of 0.06 ± 0.01 mm.

Lelo Hex Lubricated Natural Rubber Latex Condom is packaged in individually sealed flexible laminate foils which is then packaged into an outer consumer cardboard carton. The Lelo Hex Lubricated Natural Rubber Latex Condom is intended for over-the-counter (OTC) use. These condoms conform with FDA-recognized standards ASTM D3492-16 and ISO 4074:2015.

The provided text describes the regulatory clearance of a medical device, the Lelo Hex Lubricated Natural Rubber Latex Condom, and references its performance testing. However, it does not explicitly define acceptance criteria in a structured table or detail a specific study proving the device meets these criteria in the way typically required for AI/ML-based diagnostic devices.

The document focuses on demonstrating substantial equivalence to a predicate device for FDA clearance. The "acceptance criteria" can be inferred from the standards the device claims to meet and the types of tests performed.

Here's an interpretation based on the provided text, structured as requested, but with caveats about the specificity of the "acceptance criteria" as defined in this context:

1. A table of acceptance criteria and the reported device performance

Note: The details of the specific quantitative acceptance criteria (e.g., exact tensile strength values, specific acceptable defect rates) from ISO 4074 or ASTM D3492 are not provided in this document, only that the device met these standards.

Regarding the study proving the device meets the acceptance criteria:

The document summarizes the performance testing conducted, which serves as the "study" proving the device meets the inferred acceptance criteria.

The following information is largely not applicable (N/A) or not available (N/A – not provided) because this is a submission for a physical medical device (condom) and not an AI/ML-based diagnostic device. The questions about test sets, experts, adjudication, MRMC studies, standalone algorithm performance, and training sets are directly relevant to AI/ML device evaluations.

2. Sample size used for the test set and the data provenance:

• Sample size: Not explicitly stated for each test, but implied to be sufficient to meet the statistical requirements of the referenced ISO and ASTM standards.
• Data provenance: Not explicitly stated, tests were presumably performed by laboratories in a controlled environment to standard specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• N/A. This question is for AI/ML diagnostics. For a physical device like a condom, "ground truth" refers to the objective measurement against established physical standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• N/A. This question is for AI/ML diagnostics.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• N/A. This question is for AI/ML diagnostics.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• N/A. This question is for AI/ML diagnostics. The device is a physical product.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Objective measurement against recognized international and national standards. For biocompatibility, it's the results from standardized biological tests. For physical performance, it's direct measurements (e.g., dimensions, burst pressure, tensile strength) compared to numerical thresholds defined in ISO 4074:2015 and ASTM D3492-16.

8. The sample size for the training set:

• N/A. This question is for AI/ML diagnostics. There is no "training set" for a physical device like this in the context of this submission. The device is developed through manufacturing processes and then tested against standards.

9. How the ground truth for the training set was established:

• N/A. This question is for AI/ML diagnostics.

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The LELO RESPECT HEX Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Not Found

The provided text is a 510(k) clearance letter from the FDA for the "LELO RESPECT HEX Natural Rubber Latex Condom." This document primarily concerns the regulatory approval of a medical device (a condom) and does not contain information about the acceptance criteria, device performance results, or study details (like sample sizes, expert qualifications, or ground truth establishment) typically associated with AI/ML device evaluations.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the necessary information is absent from this document. The document confirms the device's substantial equivalence to a predicate device for contraception and prophylactic purposes.

Ask a specific question about this device

The Lelo Hex Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Not Found

This document is a 510(k) clearance letter for a medical device: the Lelo Hex Natural Rubber Latex Condom. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. The letter confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory obligations.

Therefore, I cannot provide the requested information based on the provided text.

Ask a specific question about this device